News

February 3, 2012 — Medtronic Inc. issued a statement on the results of two studies evaluating the use of the Medtronic CoreValve system delivered through the direct aortic implantation approach. Data presented at the Society of Thoracic Surgeons (STS) 48th annual meeting demonstrate positive outcomes when the CoreValve system is implanted using the direct aortic approach, which received CE mark in November 2011. The direct aortic approach is also being evaluated in the Medtronic CoreValve U.S. pivotal trial.

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February 2, 2012 — Abiomed Inc. announced that initial clinical data from the safety study for Symphony was presented by Renzo Cecere, M.D., FRCSC, FACS, associate professor of surgery at McGill University, during the late-breaking clinical trials session at the Society of Thoracic Surgeons (STS) 2012 meeting in Fort Lauderdale, Fla.

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Technology

February 2, 2012 — GE Healthcare announced Innova image guided systems (IGS) 620 and 630, its next generation of electrophysiology (EP) biplane X-ray imaging.

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February 2, 2012 — The U.S. Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

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February 2, 2012 — Aria Health, the largest healthcare provider in Northeast Philadelphia and Bucks County, is the first on the East Coast to utilize Epoch, the latest generation of the Stereotaxis Magnetic Navigation System.

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February 2, 2011 – Biotronik has successfully completed its final interoperability testing process for Biotronik Home Monitoring, an Internet-based system for patient and implantable cardiac device information.

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February 2, 2012 — AngioDynamics entered into a definitive agreement to acquire privately held Navilyst Medical in a transaction valued at $372 million based on the Jan. 30 closing stock price of $14.20.

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Feature | Dave Fornell

Interest has exploded over the past year in robotic cath lab guidance technology since Corindus began its U.S. Food and Drug Administration (FDA) pivotal trial. The Corindus CorPath 200 robotic-assisted percutaneous coronary intervention (PCI) system has been designed to provide precise, robotic-assisted placement of coronary guide wires and stent/balloon catheters in PCI procedures.

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Feature | Dave Fornell

Based on my observations and those of the doctors on the Diagnostic & Interventional Cardiology Editorial Advisory Board, we created the following list of predictions of what will be hot trends to watch in 2012.

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Feature | Vascular Closure Devices | Dave Fornell

Manual compression remains the gold standard of care in sealing interventional access site wounds, but there is a trend toward newer technologies that promise to simplify post-operative care for nursing staff, requiring less monitoring time, helping increase patient throughput and maximizing the use of staff time.

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Feature | Dave Fornell

The key players in the U.S. defibrillator-monitor market are Physio-Control, Philips and Zoll. These systems offer much more robust capabilities than consumer-grade automatic external defibrillators (AEDs). Today’s defibrillator-monitors offer 12-lead electrocardiograms (ECGs), remote wireless transmission of these waveforms to hospitals ahead of a patient’s arrival, and additional vital signs data. The systems are designed for use by both emergency medical services (EMS) and hospital code-blue teams.

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Case Study

Sudden cardiac arrest and acute myocardial infarction are two of the largest public health problems facing Western medicine. To improve this situation, access to accurate data to measure and benchmark treatments and outcomes is vital. Over the past two decades, Zoll Medical Corp. has built a suite of products for emergency medical service (EMS) and hospitals to address these issues and drive improvements in outcomes. More recently, Zoll’s focus has been on data integration, enabling data from multiple sources to provide a complete picture of patient care in these settings.

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Feature | Dave Fornell

With the approval of the Sapien valve in November 2011, transcatheter aortic valve implantation (TAVI) technology is expected to revolutionize heart valve replacement with a minimally invasive procedure to replace open-heart surgery. However, it requires a good deal of planning, sizing and anatomical assessment of access routes using computed tomography (CT) scans with manipulation by advanced visualization software.

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Feature | By Attapoom Susupaus, M.D. and S. Chris Malaisrie, M.D., Northwestern University

Recently, the U.S. Food and Drug Administration (FDA) has approved the Edwards Sapien transcatheter heart valve for patients with aortic stenosis (AS), who are not suitable for standard aortic valve replacement (AVR). This approval is a landmark event in cardiac medicine and will change the way patients with aortic valve disease are treated.

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Case Study

When the time nears for quarterly submissions to the American College of Cardiology (ACC)-National Cardiovascular Data Registry (NCDR), most hospital cardiology departments around the country are scrambling. Numerous staff must work feverishly to manually collect the necessary information from different patient charts and then validate the accuracy of that data. It’s tedious, expensive and – thanks to information technology – unnecessary.

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